Errata - English

(Note: This errata applies to the new USP-NF ONLINE platform only.)
Line 4 of USP Reference Standards <11>: Change
USP Doxazosin Related Compound C RS
to:
USP Miconazole Related Compound C RS
AND
Line 7 of USP Reference Standards <11>: Change
USP Econazole Nitrate RS
to:
USP Miconazole Related Compound F RS

In Labeling: Change
The label states the Latin binomial(s) of one or several Salix species included in the article.
to:
The label states the Latin binomial(s) of one or several Salix species included in the article. Dosage forms prepared with this article should bear the following statement: Not for use in children, women who are pregnant or nursing, or by persons with known sensitivity to aspirin.
AND
In USP Reference Standards <11>: Delete
(This monograph is postponed indefinitely.)

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

In USP Reference Standards 〈11〉/USP Cefdinir Related Compound A RS: Change
413.43
to:
413.42
AND
In USP Reference Standards 〈11〉/USP Cefdinir Related Compound B RS: Change
C₁₄H₁₃N₄O₄S₂ 365.41
to:
C₁₄H₁₄N₄O₄S₂ 366.41

In Labeling: Change
It meets the labeling requirements of Botanical Extracts <565>.
to:
It meets the labeling requirements of Botanical Extracts <565>. Dosage forms prepared with this article should bear the following statement: Not for use in children, women who are pregnant or nursing, or by persons with known sensitivity to aspirin.
AND
In USP Reference Standards <11> : Delete
(This monograph is postponed indefinitely.)

Change
Where tetracycline hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.
to:
Where Tetracycline Hydrochloride must be sterile or subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.

Line 2 of USP Ethinyl Estradiol Related Compound B RS: Change
19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol.
C₂₀H₂₂O₂ 294.39
to:
19-Nor-17ɑ-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol monohydrate.
C₂₀H₂₂O₂ · H₂O 312.40

In USP Lansoprazole Related Compound B RS: Change
2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-pyridin-2-yl] methyl]sulfanyl]-1H-benzimidazole.
C₁₆H₁₄F₃N₃OS 353.36
to:
2-{[(3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl]thio}benzimidazole monohydrate.
C₁₆H₁₄F₃N₃OS · H₂O 371.38

In USP Succinylmonocholine Chloride RS: Change
Ethanaminium, 2-(carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride.
to:
Ethanaminium, 2-(3-carboxy-1-oxopropoxy)-N,N,N-trimethyl-, chloride;
Also known as 2-[(3-Carboxypropanoyl)oxy]-N,N,N-trimethylethan-1-aminium chloride.

In USP Cetirizine Related Compound A RS: Change
2-(2-{4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl}ethoxy)acetic acid, ethyl ester dihydrochloride.
C₂₃H₂₉ClN₂O₃ · 2HCl 489.86
to:
(RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester oxalate.
C₂₃H₂₉ClN₂O₃ · C₂H₂O₄ 506.98

In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
C₃₂H₃₇NO₄ 538.12
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
C₃₂H₃₇NO₄ 499.65

In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt form.] 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hydrochloride.

In USP Pantoprazole Related Compound E RS: Change
A mixture of the stereoisomers of 6,6′-bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazolyl.
to:
6,6′-Bis(difluoromethoxy)-2,2′-bis[[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl]-1H,1′H-5,5′-bibenzimidazole.

In USP Clomiphene Related Compound A RS: Change
(E,Z)-2-[4-(1,2-Diphenylethyl)phenoxy]-N,N-diethylethanamine hydrochloride.
to:
(E,Z)-2-[4-(1,2-Diphenylvinyl)phenoxy]-N,N-diethylethanamine hydrochloride.
Also known as (E,Z)-2-[4-(1,2-Diphenylethenyl)phenoxy]-N,N-diethylethanamine hydrochloride.

In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.

In USP Mirtazapine Resolution Mixture RS: Change
Impurity D: 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine.
to:
Impurity D: [Note–This impurity may be available either as the free base form or as the hydrochloride salt form.] 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine or 1,2,3,4,10,14b-Hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hydrochloride.

In USP Bendamustine Related Compound B RS: Change
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)butanoic acid.
C₁₆H₂₁N₃O₃ 303.36
to:
4-(1-Methyl-5-morpholino-1H-benzimidazol-2-yl)butanoic acid hydrochloride.
C₁₆H₂₁N₃O₃ · xHCl

In USP Levalbuterol Related Compound D RS: Change
5-{2-[(1,1-Dimethylethyl)amino]-1-hydroxyethyl}-2-hydroxy-benzaldehyde.
C₁₃H₁₉NO₃ 237.29
^▲[NOTE—This may be available as the sulfate salt (2:1).]_{▲ (USP 1-May-2019)}
to:
5-[2-(tert-Butylamino)-1-hydroxyethyl]-2-hydroxybenzaldehyde sulfate (2:1) (salt);
Also known as 5-[2-{(1,1-Dimethylethyl)amino}-1-hydroxyethyl]-2-hydroxy-benzaldehyde sulfate (2:1).
(C₁₃H₁₉NO₃)₂ · H₂SO₄ 572.67

Line 2 of USP Miconazole Related Compound C RS: Change
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine.
C₁₅H₁₃Cl₄NO 365.08
to:
2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethan-1-amine hydrochloride.
C₁₅H₁₃Cl₄NO · HCl 401.53

In USP Doxycycline Related Compound A RS: Change
444.43
to:
444.44
AND
Change
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.13
to:
(4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride.
C₂₂H₂₄N₂O₈ · HCl 480.90

In USP Fexofenadine Related Compound A RS: Change
Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.
to:
2-(4-{4-[4-(Hydroxydiphenylmethyl)piperidin-1-yl]butanoyl}phenyl)-2-methylpropanoic acid;
Also known as Benzeneacetic acid, 4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl.

Line 2 of USP Doxepin Related Compound C RS: Change
(E,Z)-3-(Dibenzo[b,e]oxepin-11(6H-ylidene)-N-methyl-propoan-1-amine.
to:
(E,Z)-3-(Dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride.

In USP Ziprasidone Related Compound F RS: Change
2-(2-Amino-5-{2-[4-(benzo[d]isothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetic acid.
C₂₁H₂₃ClN₄O₂S 430.95
to:
Sodium 2-(2-amino-5-{2-[4-(benzisothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetate monohydrate;
Also known as Sodium 2-(2-amino-5-{2-[4-(benzo[d]isothiazol-3-yl)piperazin-1-yl]ethyl}-4-chlorophenyl)acetate monohydrate.
C₂₁H₂₂ClN₄NaO₂S · H₂O 470.95

In USP Ondansetron Related Compound A RS: Change
3-[(Dimethylamino)methyl]-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride.
C₁₆H₂₀N₂O · HCl 292.80
to:
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one hydrochloride.
C₁₆H₂₀N₂O · HCl 292.81
AND
In USP Ondansetron Related Compound D RS: Change
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.
to:
9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one.

In USP Atorvastatin Related Compound C RS: Change
Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
to:
Calcium (3R,5R)-7-[2,3-Bis(4-fluorophenyl)-5-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as Difluoro impurity, or (3R,5R)-7-[3-(phenylcarbamoyl)-4,5-bis(4-fluorophenyl)-2-isopropyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
AND
In USP Atorvastatin Related Compound D RS: Change
Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
to:
3-(4-Fluorobenzoyl)-2-isobutyryl-N,3-diphenyloxirane-2-carboxamide; Also known as Epoxide impurity, or 3-(4-fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic acid phenylamide.
AND
In USP Atorvastatin Related Compound E RS: Change
3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.34
to:
Calcium (3S,5S)-7-[2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate (1:2); Also known as 3S,5S Enantiomer, or (3S,5S)-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid, calcium salt.
C₆₆H₆₈CaF₂N₄O₁₀ 1155.38
AND
In USP Atorvastatin Related Compound H RS: Change
540.62
to:
540.64
AND
In Atorvastatin Related Compound I RS: Change
654.81
to:
654.82